5154_100054106834_211950_nCongress passed the Food Safety Modernization Act to address the increasing problem of foodborne illnesses. But Congress left a lot of the details up to the Food & Drug Administration (FDA), and FDA is abusing that authority! The agency has proposed new regulations that pose significant problems for farmers, local food producers, and food hubs across the country. There are 2 proposed rules, The “Produce Rule” and the “Preventative Controls Rule”.
Under the proposed regulations, many farmers will be forced to comply with high-cost, industrial-scale regulations, and a greatly reduced ability to use natural fertilizers. Food hubs and local food businesses will be forced to deal with costly and burdensome paperwork. The costs will have to be passed on to consumers who seek out healthy, wholesome local food.
These regulations will not improve food safety – if anything, they will hurt food safety by driving small farmers out of business and increasing our reliance on imported foods.
Congress included a very important provision in the food safety law to exempt small-scale, direct-marketing producers from the new federal regulations. But the law allows FDA to take away the exemption, and the FDA has proposed regulations that would leave small farmers and food producers at the mercy of an individual bureaucrat’s discretion, with little to no recourse. In practical terms, any farmer or food processor targeted by the FDA for revocation of its exemption will almost certainly go out of business.
It’s vital that everyone who is concerned with the survival of sustainable agriculture and the local food movement submit comments to the agency before the November 15th deadline. Please take a few minutes to do both of the following:
1) submit comments to the FDA, and
2) contact your federal elected officials.
What’s wrong with the proposed FDA regulations?
They’re too expensive. By FDA’s own estimates, the proposed regulations will cost even small farmers thousands of dollars, and will cost mid-size family farms much more. Farmers do not have enough of a profit margin to absorb these costs, and they will either go out of business or be forced to dramatically increase their prices.
They empower individual agency officials to force a small farm – which should be exempt from the regulations – to comply with extensive, burdensome regulations without presenting any proof of a real public health threat.
They fail to give local farmers and food producers the basic due process protections. If an FDA official decides to revoke a small producer’s exemption, the producer has no effective opportunity to respond or defend themselves. In just 60 days, producers could find themselves put out of business.
They make it nearly impossible to use natural fertilizers. The proposed rules would require farmers to wait 6 weeks between applying heat-treated compost and harvesting the crop, which makes it difficult to use compost in many cases. The rules go much further, and require a nine MONTH waiting period between applying manure, static compost, worm casting, compost teas, or many other natural fertilizers and harvesting the crop – making it effectively impossible to use these proven, safe methods for growing crops.
They require excessive water testing and set unreasonable standards. The rules require farmers to test their water sources every single week, and to stop using water that tests positive. The tests alone could cost thousands of dollars a year, and the inability to use certain water sources – many of which pose no threat of illness to people – will make farming impossible for some farmers.
They discriminate against diversified farms, which are healthy for both people and our environment. The regulations require farmers to take steps to prevent contamination by domestic livestock or wildlife, which sounds reasonable – but the rules leave the decision about what is required almost entirely to the discretion of individual inspectors. In other words, farmers could be required to build expensive fences around their crops, destroy wildlife habitat, stop using draft horses, or other difficult and unnecessary measures. For sustainable, diversified farms, these regulations would impose significant expense and many simply will not be able to come into compliance.
They treat many low-risk activities as if they were high-risk. Farmers who run a joint CSA where they handle each others’ produce, or farmers who sell each others’ products at a farm stand, will be forced to create a costly and difficult HARPC plan. Farmers who make low risk products like pickles or jams, or who mill grains or dehydrate vegetables, will also have to spend thousands of dollars on these paperwork requirements.
Congress included a very important provision in the Food Safety Modernization Act to exempt small-scale, direct-marketing producers. Specifically, under the Tester-Hagan amendment, farmers and food producers who sell less than $500,000 annually, and who sell more than half of their products directly to consumers or local restaurants and retailers, are exempt from the new regulations.
But the FDA’s proposed regulations don’t fulfill the intent of the provision. First, the FDA wants to judge farmers’ sales based on all their sales, not just the food that is subject to FDA regulation. This means that many diversified farmers will be unable to qualify for the exemption, even if they are raising only small amounts of food that is covered by the law.
Second, the FDA wants to be able to revoke farmers’ and producers’ exemptions without respecting basic principles of fairness and due process. As proposed, the regulations:
Leave too much discretion in the hands of individual FDA officials;
Do not give small farmers and local food producers enough opportunity to respond to a decision to end their exemption; and
Do not give small farmers and local food producers enough time to comply with the rules if their exemption is revoked.
In essence, this means that any farmer or producer targeted by the FDA for revocation of its exemption will almost certainly go out of business. The number of producers targeted this way by the FDA is likely to be small, but it will be devastating for those affected. And the uncertainty of not knowing who might be the agency’s next target will have a chilling effect on many small producers.
For farmers who don’t qualify for the Tester-Hagan exemption or whose exemption is revoked, the proposed produce safety regulations cover every aspect of growing and harvesting crops. Overall, the agency has taken a “guilty until proven innocent” approach to many traditional farming practices, forcing farmers to present scientific evidence in order to continue using farming methods that have been used for decades or even centuries.
FDA’s second rule, on Preventive Controls, deals with anyone who is handling or processing food. For producers who don’t qualify for the Tester-Hagan exemption or whose exemption is revoked, the Preventive Controls rule requires that any business that packs, holds, processes, or manufactures food creates a Hazard Analysis and Risk-based Preventive Control (HARPC) plan.
This encompasses a large number of low-risk activities that farms, food hubs, and cooperative produce distributors normally conduct. All of the following would be subject to the new requirements:
A farm that dehydrates fruits, makes pickles, or mills grains;
Two farms running a joint CSA and handling each other’s produce;
A farm that stores food from any other farm or producer (even if they do no processing);
All sorts of “food hubs” that distribute food from multiple local producers.
A producer subject to this rule must develop a HARPC plan. Developing such plans can cost thousands of dollars – up to $20,000 – for a small operation in the first year. The rule then requires annual “verification” that the plan is working, with records of this verification process and its findings, at continued significant expense.
The scope and complexity of the paperwork that will be required is daunting for both on-farm and off-farm processors. In the early 1990s, similar HACCP requirements led to many small- and mid-scale slaughterhouses having to shut their doors. The FDA’s proposed rule has the potential to put an end to many of the exciting innovations taking place right now with local food hubs, community processing facilities, and the other infrastructure so vital to re-establishing local food systems.
In addition, while not spelled out in the proposed rule, the references to “source verification” could easily lead to a requirement that all the producer’s sources be similarly regulated. In other words, a food hub or other regulated facility might not be able to purchase food or ingredients from farms and facilities that are exempt from some federal regulations — such as those protected by the Tester-Hagan exemption. The proposed regulation does not explicitly require this, but it does lay the foundation for such a step.
The deadline for submitting comments to the FDA is November 15.
Take Action: Submit Comments to the FDA
To submit comments online, go to:
On-Farm Produce Rule:
Preventive Controls / HARPC Rule:
Steps for submitting comments online:
We recommend that you write your comment ahead of time and save it on your computer — there is a time limit when using the Federal Register System, and you may get timed out if you write your comment from scratch.
If your comment is less than one page, you can copy and paste it into the comment box. If it is longer, you can instead write “see attached” and UPLOAD a separate document, such as a Word or PDF file, with your comments.
Uncheck the box that says “I am submitting on behalf of a third party,” so that you do not have to enter an organization name.
For category, select “individual consumer” or “private industry”
Click “continue.”
Check the box that you have read and understood the statement, and be sure to click “submit comment.” You should be taken to a new screen with a confirmation number
Remember, many provision that affect local farms are found in both rules so be sure to submit them on both rules.
It is vital that your elected officials know how you feel about your food!
Find out who represents you by going to www.house.gov and www.Senate.gov or by calling the Capitol Switchboard at 202-224-3121.
Call and ask to speak to the staffer who handles agricultural issues. Explain that you’re a constituent and that high-quality food is very important to you. Ask your Congressman to contact FDA directly on behalf of you and other constituents.
Get the staffer’s email address and follow up by sending them a copy of your comments to FDA.
For more information please visit http://mfbf.net/PleaseCommentonFoodSafetyModernizationAct/tabid/564/Default.aspx